| Primary Device ID | 06932562310362 |
| NIH Device Record Key | 68332c17-8db4-4e52-889d-bf2fea7833d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | handheld monitor |
| Version Model Number | M800 |
| Company DUNS | 530120146 |
| Company Name | Guangdong Biolight Meditech Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06932562310362 [Primary] |
| HGM | System, Monitoring, Perinatal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-08 |
| Device Publish Date | 2024-03-29 |
| 06932562310355 - Fingertip Pluse Oximeter | 2024-04-08 |
| 06932562310362 - handheld monitor | 2024-04-08 |
| 06932562310362 - handheld monitor | 2024-04-08 |
| 06932562310317 - Fingertip Pulse Oximeter | 2021-11-10 |
| 06932562310324 - Fingertip Pulse Oximeter | 2021-11-10 |
| 06932562310348 - Fingertip Pulse Oximeter | 2021-07-06 |
| 06932562310331 - patient monitor | 2020-08-18 |
| 06932562310300 - Vital Signs Monitor | 2020-02-06 |
| 06932562310089 - Patient Monitor | 2020-02-06 The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological paramet |